Pregnancy Surveillance Program for Epidiolex/Epidyolex Exposure
This study is looking at the health of pregnant individuals and their babies after exposure to Epidiolex/Epidyolex. Researchers want to understand pregnancy-related health outcomes in people who took Epidiolex/Epidyolex (an oral solution) during pregnancy, or in the 13 days before their last menstrual period. They will follow the babies for up to 12 months after birth. To join, you must have been exposed to Epidiolex/Epidyolex during this time and give your consent. The main goal is to measure the rate of maternal complications (MCM). The study is currently observational, meaning researchers are watching what happens rather than giving a specific treatment, and the status of recruitment is unclear.
- Study design
- This is an observational study, meaning researchers will collect information without giving a specific treatment. It plans to enroll 50 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants and their infants will be followed for up to 12 months after birth.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pregnancy Surveillance Program of Patients Exposed to Epidiolex/Epidyolex During Pregnancy
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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What this trial measures
- Rate of MCMUp to 12 months post birth
Rate of Major congenital malformation (MCM) identified in the developing neonate and infant through 12 months of age